Associate Director, Data ManagementApogee Therapeutics • Saint Paul, Illinois, United States
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Associate Director, Data Management
Apogee Therapeutics
- Saint Paul, Illinois, United States
- Saint Paul, Illinois, United States
Über
Apogee Therapeutics is a clinical‑stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets. Our antibody programs are designed to overcome limitations of existing therapies by targeting well‑established mechanisms of action and incorporating advanced antibody engineering to optimize half‑life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD) and asthma. With four validated targets in its portfolio, Apogee aims to achieve best‑in‑class efficacy and dosing through monotherapies and combinations of its novel antibodies.
We are a fast‑paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient, and Egoless, and a commitment to refusing to stop at “good enough”.
Role Summary Associate Director, Data Management – Impact multiple high‑impact programs at Apogee Therapeutics. Manage both the operational and technical aspects of data management for clinical trials from Phase I through Phase IV, including planning, execution, and interpretation of all related activities.
Key Responsibilities
Provide operational leadership for the design, planning, execution, collection, and handling of all clinical data to the highest quality standards.
Coordinate and participate in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports.
Ensure the quality of clinical data within EDC systems at database snapshots and database locks, documenting and managing all related processes.
Work closely with CROs to prepare and ensure proper development and execution of data management activities.
Review protocols to ensure database feasibility.
Oversee all CRO data management deliverables.
Design and build eCRFs, database interfaces, programmed edit checks, external data files, and CRF completion guidelines in a standard, accurate, and consistent format to produce datasets conducive to analysis and regulatory submissions.
Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high‑quality data in a timely manner.
Document and archive standards for data management deliverables, ensuring audit‑ready state.
Ensure complete and accurate supporting documentation for regulatory submission, including raw datasets and annotated CRFs.
Develop, maintain, and govern CDM standards (standard eCRFs, CDASH, etc.).
Conduct data management activities in accordance with GCP, GCMP, internal SOPs, and regulatory requirements.
Ideal Candidate
Bachelor’s Degree in a health‑related field.
Minimum of 8 years of clinical data management experience in pharma, biotech, or healthcare.
Extensive experience in design, execution, collection, and cleaning of data for clinical studies.
Technology proficiency, including Data Management Systems and knowledge of GCP/ICH Data Quality requirements.
Experience managing CROs and other data vendors.
Submission experience (NDA, sNDA, BLAs).
Knowledge of Good Clinical Practice.
EDC and eCOA experience (Medidata, Veeva, etc.).
Excellent written and oral communication skills.
Strong leadership with a growth mindset, dedicated to promoting a psychologically safe environment.
Ability to keep pace in a fast‑moving organization and navigate ambiguity.
Experience working in a remote virtual environment.
Demonstrated commitment to Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless.
Position requires up to 15% travel, including mandatory in‑person attendance at All Hands meetings typically held twice per year.
The anticipated salary range for this role is $180,000–$195,000. The final salary offered will depend on relevant years of experience, educational background, and geography.
What We Offer
A culture grounded in our C.O.R.E. values.
Opportunity to work in a fast‑paced, highly dynamic environment and shape the company culture.
Market‑competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
Competitive time off: three weeks of PTO, two one‑week company‑wide shutdowns a year, and dedicated paid sick leave.
Commitment to professional growth and access to resources for development.
Regular all‑team, in‑person meetings to build relationships and solve problems.
E-Verify Participation As part of the I9 verification of authorization to work in the US, Apogee participates in E‑Verify. To learn more about E‑Verify, please review this poster.
Equal Opportunity Employer Apogee Therapeutics is proud to be an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
To review our privacy policy, click here.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Sprachkenntnisse
- English
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